EMA Announces Pharmacovigilance Fee Increase

Regulatory NewsRegulatory News | 18 October 2018 |  By 

Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.
Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.
The increased fee rate was established under Commissioner Delegated Regulation (EU) 2018/1298, which was adopted in September.
According to EMA, applications received by or with a data lock point (DLP) of 17 October 2018 or earlier will be charged the previous fee rate, and all applications received after that date will be assessed the adjusted fee.
For most pharmacovigilance fees, drugmakers should round the amount to the nearest ‎€10. The annual fee for information technology systems and literature monitoring are rounded to the nearest ‎€1.
In January, pharmacovigilance fees rose by 1.4% to account for inflation in 2015 and 2016 after not being adjusted in 2017.
EMA, Explanatory Note on Pharmacovigilance Fees Payable to the European Medicines Agency


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